Open-Label Extension Study of the Effects of Pomegranate Extract on Rising PSA After Primary Therapy for Prostate Cancer - Full Text View

Sponsor:	Radiant Research
Collaborator:	Roll International Corporation
Information provided by:	Radiant Research
ClinicalTrials.gov Identifier:	NCT00731848

Purpose

This study is an open-label extension to the double-blind GUP-0205-1 study. High concentrations of anti-oxidants in pomegranate seeds present a potential strategy to delay clinical prostate cancer progression and prolong the interval from treatment failure to hormonal ablation. Eligible male subjects were previously assigned to the placebo group in the double-blind study and were diagnosed with disease progression while on placebo treatment. Upon satisfying all entry criteria, the subjects will receive open-label pomegranate extract for up to 48 months in the absence of further disease progression or intolerable toxicity.

Condition	Intervention	Phase
Prostate Cancer	Other: pomegranate liquid extract	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title:	An Open-Label Extension Study of the Effects of Pomegranate Extract on Rising Prostate-Specific Antigen Levels in Men Following Primary Therapy for Prostate Cancer.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by Radiant Research:

Primary Outcome Measures:

The within-subject difference between the PSA doubling time from the end of double-blind placebo treatment to the end of open-label pomegranate extract treatment. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The effect of treatments on response rates for positive PSA doubling times (greater than 150% baseline), and for negative post-treatment PSA doubling time (i.e., declining PSA), and for changes in absolute PSA values. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	February 2008
Estimated Study Completion Date:	January 2015
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Intervention 1	Other: pomegranate liquid extract Pomegranate liquid extract, 8 oz per day, for 52 weeks

Detailed Description:

This study is an open-label extension to the double-blind GUP-0205-1 study. Eligible male subjects, i.e.,men who had rising PSA levels following primary therapy for localized prostate cancer, were previously assigned to the placebo group in the double-blind study and were diagnosed with disease progression while on placebo treatment. Upon satisfying all entry criteria, the subjects will receive open-label pomegranate extract for up to 48 months in the absence of further disease progression or intolerable toxicity.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Documented disease progression while on placebo in GUP-0205-1 (a > 100% increase in serum PSA [with a minimum value of 1.0 ng/mL]).
Willingness and ability to sign an informed consent document.
Agreement with complete abstinence from other commercially available pomegranate products during the course of the study.
Use of dietary/herbal supplements (e.g., saw palmetto, selenium, etc) are acceptable provided the dose has been stable for at least 2 months prior to screening and the subject agrees not to change/stop during the course of the study.

Exclusion Criteria:

Significant concomitant medical or psychiatric condition that, in the opinion of the investigator, would make the subject a poor protocol candidate.
Hormonal therapy, with the exception of neoadjuvant androgen deprivation therapy (ADT) prior to or concurrent with primary therapy. Subjects who underwent neoadjuvant ADT cannot have a serum testosterone of ≤150 ng/mL at study entry.
Concomitant or antecedent hormonal therapy for rising serum PSA after initial therapy of prostate cancer.
Subjects unable or unwilling to comply with protocol requirements.
Prior treatment with experimental drugs, high dose steroids, or with any other cancer treatment within 4 weeks prior to the first dose of study product and for the duration of the study.
Serum PSA >7.0 ng/mL (assessed at termination of the double-blind study; at any PSA level, the subject will be excluded if determined by the investigator that the subject's continued participation would not be in their best interest).
Serum PSA doubling time <13 weeks (assessed at termination of the double-blind study).
Evidence of metastatic disease on physical examination or on CT or bone scan.
Use of finasteride, dutasteride at any point since primary therapy or during the study.
Clinically significant abnormal laboratory value greater than 2 times the upper limit of normal (>2XULN).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00731848

Contacts

Contact: Cecilia Belmonte

312-494-2299

ceciliabelmonte@radiantresearch.com

Locations

United States, California
UCLA School of Medicine	Recruiting
Los Angeles, California, United States, 90095
Contact: Allan J Pantuck, MD 310-206-2436 apantuck@mednet.ucla.edu
Contact: Arie S Belldegrum, MD 310-206-1434 abelldegrun@mednet.ucla.edu
Principal Investigator: Allan J Pantuck, MD
Principal Investigator: Arie S Belldegrun, MD

Sponsors and Collaborators

Radiant Research

Roll International Corporation

Investigators

Principal Investigator:	Allan J Pantuck, MD	University of California, Los Angeles
Principal Investigator:	Arie S Belldegrun, MD	University of California, Los Angeles

More Information

No publications provided

Responsible Party:	Radiant Research ( Michael H. Davidson, MD, Executive Medical Director )
Study ID Numbers:	GUP-0205-1X
Study First Received:	August 7, 2008
Last Updated:	August 8, 2008
ClinicalTrials.gov Identifier:	NCT00731848 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Radiant Research:

prostate cancer
prostate-specific antigens
PSA

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010